Varenicline Tartarate Mono Nitro Impurity (impureza de varenicline | varenicline Impurity 1; CAS 230615-53-9) es una impureza orgánica relevante identificada en lotes de API que requiere monitoreo riguroso por su posible impacto en pureza y perfil de seguridad. Se caracteriza por la presencia del grupo nitro mono que altera polaridad y espectroscopía | permitiendo su detección por HPLC-UV | LC-MS y confirmación estructural mediante RMN. Para control de calidad se recomienda desarrollo y validación de métodos de cuantificación con límites de detección y cuantificación compatibles con especificaciones regulatorias | estudios de estabilidad forzados para evaluar su formación y estrategias de purificación dirigidas.
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![1-((1R,5S)-8-amino-6-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)-2,2,2-trifluoroethan-1-one](https://veeprho.com/wp-content/uploads/2022/11/1-1R-5S-8-amino-6-nitro-1-2-4-5-tetrahydro-3H-1-5-methanobenzo-d-azepin-3-yl-2-2-2-trifluoroethan-1-one.png "1-((1R,5S)-8-amino-6-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)-2,2,2-trifluoroethan-1-one")
